A Safety and Efficacy Study to Evaluate AIV001 in Wound Healing Following Surgical Incision

Phase 1

Completed

• Conditions: Scar; Incision; Abdominal; Wound (Morphologic Abnormality)
• Interventions: Drug: AIV001

• Registration Number: NCT03639883
• Lead Sponsor: AiViva BioPharma, Inc.

Brief Summary

To evaluate the safety, efficacy and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with incisional wounds

Detailed Description

This is primarily a safety study to evaluate the safety of AIV001 when administered near incisional wounds. A unique model was used to assess incisional scarring, safety and biomarker assessments. Women electing to have the abdominoplasty procedure were enrolled in the study and abdominal incisions were generated on the abdominal skin. Up to 10 incisions were made on abdominal skn and treated as assigned. And data collection was conducted up to day 49 when the subjects were exited from the study and the abdominoplasty procedure performed. Exploratory efficacy measures were collected and pharmacokinetic profiles determined.

Study Timeline

• Study First Submitted: 2018-08-16
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-21
• Study Start: 2018-11-05
• Primary Completion: 2019-12-04
• Study Completion: 2019-12-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Eligible for an abdominoplasty
• Nonsmoker
• Fitzpatrick I-IV
• Weight >45Kg
• BMI <= 35

Exclusion Criteria

• Existing scars in study area, active infection
• Any medical history or present conditions that may increase the risk associated with study participation or investigational product administration and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
0.033% versus Vehicle	AIV001	One side of the subject will receive 0.033% AIV001 and the other side of the subject will receive vehicle.
0.1% versus Vehicle	AIV001	One side of the subject will receive 0.1% AIV001 and the other side of the subject will receive vehicle.
0.3% versus Vehicle	AIV001	One side of the subject will receive 0.3% AIV001 and the other side of the subject will receive vehicle.
1% versus Vehicle	AIV001	One side of the subject will receive 1% AIV001 and the other side of the subject will receive vehicle.

Primary Outcome Measures

Name	Time	Method
Adverse events	Day 1 through Day 49	Local and systemic adverse events

Secondary Outcome Measures

Name	Time	Method
Efficacy using Patient and Observer Scar Assessment Scale (6 parameters, 1 normal to 10 worst imaginable)	Day 7 through 49	Evaluation of the healing of the wounds
Modified Vancouver Scar Scale (4 parameters, 0 = normal to 3 or 4 = severe)	Day 7 through 49	Evaluation of the healing wounds
100 mm Visual Analogue Scale (0 = normal to 10 = poor scar)	Day 7 through 49	Evaluation of healing wounds

Trial Locations

Locations (2)

Kaufman and Davis Plastic Surgery; 🇺🇸 Folsom, California, United States

Cosmetic Laser Dermatology; 🇺🇸 San Diego, California, United States